Drug product
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
D-1296-2020
Product summary
- Event
- Event 85504
- Status
- Terminated
- Classification
- Class I
- Quantity
- 5,314,400 vials
- Official record key
drug-enforcement:D-1296-2020
Official wording
Reason: Presence of Particulate Matter - found in reserve sample vials at the firm.
Code information: Lot #: 6118737, 6118902, Exp 04/2020; 6119052, Exp 05/2020; 6119752, Exp 08/2020; 6122349, Exp 07/2021; 6122538, Exp 09/2021
Distribution pattern: USA Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter